Data for: "Proof-of-concept trial of electronic monitoring devices for adolescents living with HIV in Zimbabwe" – Data Codebook

Persistent identifier

10.17037/DATA.00005346

Description

The VITALITY randomised controlled trial investigated the effectiveness of vitamin D and calcium supplementation on bone density in adolescents living with HIV. Nested within VITALITY, this pilot trial investigated the effectiveness of electronic monitoring devices (EMDs) on adherence to vitamin D supplementation in Harare, Zimbabwe.

169 adolescents living with HIV were randomised to receive an EMD (N=97) or no EMD (n=72) for 24 weeks. 84 of the adolescents were taking vitamin D supplements (N=50 with EMD, N=34 without EMD). The pilot trial compared 25OHD levels in blood between the EMD and non-EMD participants receiving vitamin D supplements after 24 weeks as a marker of adherence.

This record contains two datasets, an R script, Stata do file, and accompanying documentation:

  1. The ‘EMD_minimal_deidentified’ dataset contains records on 97 participants who were randomly allocated to receive an electronic monitoring device and 72 participants who were randomly allocated to not receive one. It can be analysed with the Stata do file “Minimal dataset.do”, which replicates the pilot trial analysis of adherence and vitamin D level by EMD arm, among those who were receiving vitamin D supplement in the parent VITALITY trial.
  2. The ‘ml_preprocessed_for_R’ dataset contains records on 97 participants who received an electronic monitoring device. It can be analysed with the R script “clustering_deidentified.R, which reproduces the unsupervised machine learning techniques for exploratory analysis of patterns of EMD use over 24 weeks, using k-means clustering, k-medoids clustering, hierarchical agglomerative clustering and Gaussian mixture model.

The original study's ethical approvals state data will be used in ethically approved research only. Data will be shared once evidence of ethics approval is provided.

Data Codebook

This record contains two datasets and accompanying scripts to analyse them:

EMD_minimal_deidentified

The ‘EMD_minimal_deidentified’ dataset contains records on 97 participants who were randomly allocated to receive an electronic monitoring device and 72 participants who were randomly allocated to not receive one. It can be analysed with the Stata do file “Minimal dataset.do”.  This do file replicates the pilot trial analysis of adherence and vitamin D level by EMD arm, among those who were receiving vitamin D supplement in the parent VITALITY trial.

The original study's ethical approvals state data will be used in ethically approved research only. Data will be shared once evidence of ethics approval is provided.

Variable Name Variable Label Answer Label Answer Code Obs Min Max Variable Type
arm VITALITY treatment arm     169 1 2 Numeric
    Intervention 1        
    Control 2        
EMD EMD arm     169 0 1 Numeric
    No EMD 0        
    Used EMD 1        
a04_sex Participant sex     169 1 2 Numeric
    Male 1        
    Female 2        
age_exact Participant age as decimal Open ended   169 11 20 Numeric
c01_enrol Enrolled in school     169 0 1 Numeric
    No 0        
    Yes 1        
c02_schtype Type of school     143 1 3 Numeric
    Primary 1        
    Secondary 2        
    College/Vocational 3        
vl10vload Viral load Open ended   169 20 487652 Numeric
vlcat viral load 3 categories     169 0 2 Numeric
    <60 0        
    60-999 1        
    >=1000 2        
sesquint SES quintile Open ended   169 1 5 Numeric
pcgiver Primary caregiver     169 1 3 Numeric
    Mother or Father 1        
    Other 3        
orphanhood Orphanhood     169 1 3 Numeric
    Both parents alive 1        
    1 or both parents deceased 2        
    Unknown 3        
base25OHD 25OHD at baseline nmolL Open ended   169 29.7 120.8 Numeric
wk4825OHD 25OHD at week 48 nmolL Open ended   167 39.2 142.2 Numeric
adhpc24 Vitamin D adherence week 0-24 Open ended   420 0 100 Numeric
adhpc48 Vitamin D adherence week 24-48 Open ended   397 0 100 Numeric

ml_preprocessed_for_R

The ‘ml_preprocessed_for_R’ dataset contains records on 97 participants who received an electronic monitoring device. It can be analysed with the R script clustering_deidentified. This R script reproduces the unsupervised machine learning techniques for exploratory analysis of patterns of EMD use over 24 weeks, using k-means clustering, k-medoids clustering, hierarchical agglomerative clustering and Gaussian mixture model.

Variable Name Variable Label Answer Label Answer Code Obs Min Max Variable Type
arm VITALITY treatment arm     97 1 2 Numeric
    Intervention 1        
    Control 2        
age Age in years Open ended   97 11 20 Numeric
sesquint SES quintile Open ended   97 1 5 Numeric
base25OHD 25OHD at baseline nmolL Open ended   97 37.9 120.8 Numeric
wk4825OHD 25OHD at week 48 nmolL Open ended   97 39.2 142.2 Numeric
vl10vload Viral load Open ended   97 20 240149 Numeric
tot1 EMD event wk 1     97 0 1 Numeric
    No 0        
    Yes 1        
tot2 EMD event wk 2     97 0 1 Numeric
    No 0        
    Yes 1        
tot3 EMD event wk 3     97 0 1 Numeric
    No 0        
    Yes 1        
tot4 EMD event wk 4     97 0 1 Numeric
    No 0        
    Yes 1        
tot5 EMD event wk 5     97 0 1 Numeric
    No 0        
    Yes 1        
tot6 EMD event wk 6     97 0 1 Numeric
    No 0        
    Yes 1        
tot7 EMD event wk 7     97 0 1 Numeric
    No 0        
    Yes 1        
tot8 EMD event wk 8     97 0 1 Numeric
    No 0        
    Yes 1        
tot9 EMD event wk 9     97 0 1 Numeric
    No 0        
    Yes 1        
tot10 EMD event wk 10     97 0 1 Numeric
    No 0        
    Yes 1        
tot11 EMD event wk 11     97 0 1 Numeric
    No 0        
    Yes 1        
tot12 EMD event wk 12     97 0 1 Numeric
    No 0        
    Yes 1        
tot13 EMD event wk 13     97 0 1 Numeric
    No 0        
    Yes 1        
tot14 EMD event wk 14     97 0 1 Numeric
    No 0        
    Yes 1        
tot15 EMD event wk 15     97 0 1 Numeric
    No 0        
    Yes 1        
tot16 EMD event wk 16     97 0 1 Numeric
    No 0        
    Yes 1        
tot17 EMD event wk 17     97 0 1 Numeric
    No 0        
    Yes 1        
tot18 EMD event wk 18     96 0 1 Numeric
    No 0        
    Yes 1        
tot19 EMD event wk 19     96 0 1 Numeric
    No 0        
    Yes 1        
tot20 EMD event wk 20     96 0 1 Numeric
    No 0        
    Yes 1        
tot21 EMD event wk 21     95 0 1 Numeric
    No 0        
    Yes 1        
tot22 EMD event wk 22     95 0 1 Numeric
    No 0        
    Yes 1        
tot23 EMD event wk 23     95 0 1 Numeric
    No 0        
    Yes 1        
tot24 EMD event wk 24     90 0 1 Numeric
    No 0        
    Yes 1        
num_extra Number of extra EMD events Open ended   97 0 10 Numeric
num_ooso Number of out-of-schedule EMD events Open ended   97 0 75 Numeric
num_timepoints Number of timepoints Open ended   97 17 24 Numeric
male Participant sex assigned at birth     97 0 1 Numeric
    Not male 0        
    Male 1        
summer_enrol Enrolment time     97 0 1 Numeric
    Oct-Nov 0        
    July-Sep 1        
orphan Orphanhood     93 0 1 Numeric
    Both parents alive 0        
    1 or both parents deceased 1        
non_parent_carer Carer     97 0 1 Numeric
    Mother or father 0        
    Other 1        
high_art_burden ART regimen at baseline     97 0 1 Numeric
    fixed dose regimen 0        
    2+ tabs regimen 1        
min_age Minimum age Open ended   97 11 11 Numeric
max_age Maximum age Open ended   97 20 20 Numeric
s_age Scaled age Open ended   97 0 1 Numeric
min_sesquint Minimum sesquint Open ended   97 1 1 Numeric
max_sesquint Maximum sesquint Open ended   97 5 5 Numeric
s_sesquint Scaled sesquint Open ended   97 0 1 Numeric
min_base25OHD Minimum base25OHD Open ended   97 37.9 37.9 Numeric
max_base25OHD Maximum base25OHD Open ended   97 120.8 120.8 Numeric
s_base25OHD Scaled base25OHD Open ended   97 0 1 Numeric
min_wk4825OHD Minimum wk4825OHD Open ended   97 39.2 39.2 Numeric
max_wk4825OHD Maximum wk4825OHD Open ended   97 142.2 142.2 Numeric
s_wk4825OHD Scaled wk4825OHD Open ended   97 0 1 Numeric
min_vl10vload Minimum vl10vload Open ended   97 20 20 Numeric
max_vl10vload maximum vl10vload Open ended   97 240149 240149 Numeric
s_vl10vload Scaled vl10vload Open ended   97 0 1 Numeric
min_num_extra Minimum number extra Open ended   97 0 0 Numeric
max_num_extra Maximum number extra Open ended   97 10 10 Numeric
s_num_extra Scaled number extra Open ended   97 0 1 Numeric
min_num_ooso Minimum number ooso Open ended   97 0 0 Numeric
max_num_ooso Maximum number ooso Open ended   97 75 75 Numeric
s_num_ooso Scaled number ooso Open ended   97 0 1 Numeric
min_num_timepoints Minimum number timepoints Open ended   97 17 17 Numeric
max_num_timepoints Maximum number timepoints Open ended   97 24 24 Numeric
s_num_timepoints Scaled number timepoints Open ended   97 0 1 Numeric